Relapsing MS patients received 300 mg TYSABRI IV every 28 days (n=627) or placebo (n=315). Patients with PPMS, SPMS, and PRMS were excluded.
83% of patients taking TYSABRI had no sustained physical disability progression for 12 weeks vs 71% with placebo (primary endpoint: 17% vs 29%; p<0.001)1,2
In an exploratory analysis of the pivotal trials:
Study description: A retrospective, exploratory analysis of the pivotal trials was performed to report the effects of TYSABRI on HRQoL as measured by the Short Form-36 (SF-36). Annualized relapse rate (ARR) was measured at 3-month intervals.3,a,b,c
The improvement of 5.0 points (SD, 0.5) in TYSABRI-treated patients was considered a clinically meaningful differenceg
EDSS=Expanded Disability Status Scale; MRI=magnetic resonance imaging; VAS=visual analog scale; PCS=Physical Component Summary; MCS=Mental Component Summary; SD=standard deviation.
aThe AFFIRM (NAtalizumab Safety and EFFlcacy in Relapsing-Remitting MS) study was a pivotal 2-year, double-blind, randomized, controlled trial with 942 relapsing MS patients who received either TYSABRI monotherapy (300 mg by intravenous infusion [n=627]) or placebo (n=315) every 4 weeks for up to 28 months (30 infusions), which excluded patients with primary progressive, secondary progressive, or progressive relapsing MS.1-3
bThe SENTINEL (Safety and Efficacy of NaTalizumab in Combination with INterferon Beta-1a in Patients With RELapsing Remitting Multiple Sclerosis): a pivotal 2-year, double-blind, placebo-controlled, parallel-group, randomized trial with relapsing MS patients who experienced one or more relapses while on treatment with interferon beta-1a (IFN-β-1a). Patients received either 300 mg TYSABRI (n=589) or placebo (n=582) every 4 weeks for up to 28 months, all patients continued to receive IFN-β-1a 30 μg IM once weekly, excluding patients with primary progressive, secondary progressive, or progressive relapsing MS.1,3,4
cThe SF-36 is a widely used, general HRQoL instrument that contains 36 items that assess patients’ health status and its impact on their lives. SF-36 HRQoL results are patient-reported.3
gThe standard minimally important difference cutoff of 5 points was used here (derived from the reference population of disease-free individuals). It may be preferable to establish a minimally important difference in patients with RMS.3